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IRX Therapeutics Announces Presentation of IRX-2 Phase 1b Biomarker Data in Early Stage Breast Cancer

— IRX-2 is well-tolerated with encouraging evidence of activity —
— Upregulation of PD-L1 and other key biomarkers observed —

NEW YORK – November 10, 2017 – IRX Therapeutics, Inc. (IRX) announced the presentation of preliminary results from a Phase 1b clinical trial of IRX-2, the company’s lead drug candidate, in early stage breast cancer (ESBC) demonstrating that IRX-2 is well-tolerated in this population and reporting early signals of activity. The results will be presented on Saturday, November 11 at the Society for Immunotherapy of Cancer’s (SITC) 31st Annual Meeting.

“The results of the on-going Phase 1b study suggests that IRX-2, a primary cell-derived biologic, is well-tolerated with no Grade 3 or 4 toxicities in patients studied to date,” said principal investigator David Page, M.D., Providence Health and Services. “In addition, these data demonstrate that IRX-2 modulates the tumor microenvironment in early stage breast cancer cells and increases stromal tumor-infiltrating lymphocytes, T-cell activation, T-regulatory cell depletion, and up-regulates PD-L1. We are encouraged by these results and are continuing to enroll patients in this study with the goal of presenting final results in 2018.”

The Phase 1b study is enrolling patients with early stage (I-III) breast cancer indicated for standard-of-care surgical lumpectomy/mastectomy. Twenty-one days prior to surgery, all patients receive a single low dose of cyclophosphamide (300 mg/m2), followed by 10 days of subcutaneous periareolar injections of IRX-2 into the affected breast. Total enrollment is expected to reach 20 patients.

In the study, most toxicities reported were Grade 1, except for one report of Grade 2 headache and one report of Grade 2 nausea. Increases in stromal tumor infiltrating lymphocytes (sTILs) were observed in 7/12 patients with a mean 52{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} relative increase (range: -25{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} to +66{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513}) and 6{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} absolute increase (range: -5{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} to +23{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513}, p=0.02 paired t-test). IRX-2 increased leukocyte recruitment as well as levels of cytotoxic markers and checkpoints. Increases in gene expression associated with tumor suppression (FOS, EGR1, EGR2, CXCL2 and CXCR4), chemotaxis (CXCL12, ITGAE, RPS6) and T-cell activation (CD59, TNFAIP3, CDKN1A) were reported as well as up-regulation of PD-L1 as measured by Nanostring and multispectral IHC.

“IRX-2 demonstrated 65{991a4518005c0acae110dc2957c3093c53aab3e18df24b42d60853d4cdca3513} 5 year survival in a Phase 2a study in squamous cell carcinoma of the head and neck and is now being studied in an on-going randomized, multi-center international Phase 2b clinical trial in SCCHN,” said Mark Leuchtenberger, President and Chief Executive Officer of IRX Therapeutics. “The results support the potential of IRX-2 as a therapeutic option in early stage breast cancer and suggests that, based on its mechanism of action, IRX-2 could have potential utility in other indications. We are very encouraged by these results and look forward to seeing the complete results of the Phase 1b trial next year.”

About IRX Therapeutics and IRX-2

IRX Therapeutics is a clinical-stage company developing novel immunotherapies focused on reducing the immune suppression that is seen in the cancer tumor micro-environment, restoring immune function, and activating a coordinated immune response against the tumor.

The lead candidate, IRX-2, is a proprietary therapeutic containing numerous active cytokine components, which data suggests may restore and activate multiple immune cell types, including T cells, dendritic cells, and natural killer cells, that are known to recognize and attack tumors. IRX-2 is a primary cell-derived biologic of produced by stimulation of human peripheral blood mononuclear cells (PBMCs) obtained from heathy donor whole blood. Data collected to date suggest that IRX-2 reduces the immune suppression that is often seen in the cancer tumor microenvironment. This immunomodulatory activity appears to occur through the restoration of immune function and activation of a coordinated immune response against the tumor.

Currently, IRX-2 is being studied in an ongoing Phase 2b clinical trial in patients with newly diagnosed Stage II, III, and IVA squamous cell carcinoma of the head and neck (SCCHN) (INSPIRE) ( NCT02609386) as well as in investigator-sponsored trials in pre-operative early stage breast cancer (ESBC) ( NCT02950259).and in cervical squamous intraepithelial neoplasia 3 (CIN3) or squamous vulvar intraepithelial neoplasia 3 (VIN3) ( NCT03267680).

For more information about the Company and its clinical programs, please visit

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